Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT00393120
Status:
COMPLETED
Last Update Posted:
2018-03-26
First Post:
2006-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'dispFirstSubmitDate': '2010-06-18', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-22', 'studyFirstSubmitDate': '2006-10-24', 'dispFirstSubmitQcDate': '2010-06-18', 'studyFirstSubmitQcDate': '2006-10-24', 'dispFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability will be assessed by monitoring adverse experiences.', 'timeFrame': 'Baseline, every 1-7 days following the initiation of treatment through Day 28 and then at Day 42 or the early study termination visit.'}], 'secondaryOutcomes': [{'measure': 'The virological response to INCB009471 as monotherapy will be assessed by measuring HIV-1 RNA levels by the Roche Amplicor HIV-1 Monitor® Test, v1.5 - Quantitative.', 'timeFrame': 'Baseline, Days 4, 7, 10, 14, 16, 20 and 28 or the early termination study visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV-infection', 'viral load', 'CCR5', 'viral tropism', 'HIV-1 infection', 'Treatment Naive'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, pharmacokinetics and efficacy of the CCR5 antagonist INCB009471 in HIV-1 infected patients who are antiretroviral therapy naïve, or who are not currently on a HAART regimen and have not received any antiretroviral agents for 3 months prior to the Screening visit. Subjects will receive study medication (INCB009471) admnistered orally or placebo once daily with food for 14 days. Clinical safety laboratories, 12-lead electrocardiograms, physical examinations and virologic assessments, including viral load, viral tropism and CD4+ cell count determinations will be performed at the Screening visit and at regularly scheduled visits throughout the study. A blood sample will also be obtained and stored to potentially determine the genotype of the CCR5 receptor.\n\nThe primary objectives are:\n\n1. Assess the safety and tolerability of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days;\n2. Determine the pharmacokinetics of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days;\n3. Evaluate the anti-retroviral activity of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAsymptomatic HIV-1 infected individuals that are treatmen naïve (ie less than 2 weeks prior ARV exposure) or treatment experienced subjects who are not currently on HAART and have not received any ARVs for 3 months prior to Screening.\n\n* Males between 18 years and 65 years of age, utilizing adequate contraceptive methods.\n* Post menopausal or surgically sterile females between 18 years and 65 years of age. Women of childbearing potential, utilizing adequate contraceptive methods.\n* CD4-lymphocyte count \\>350 cells/mm3\n* HIV-1 RNA copies/ml \\> 10,000.\n* HIV-1 is CCR5 tropic virus only.\n* CCR5 antagonist treatment naive.\n* BMI \\> 16 to \\< 32 kg/m2.\n* Have no clinically significant findings on screening evaluations, which in the opinion of the Investigator would interfere with the subject's ability to comply with the protocol.\n* Able to comprehend and willing to sign an Informed Consent Form.\n\nExclusion Criteria:\n\n* Current or recent (\\<30 days) opportunistic infection.\n* Presence of CXCR4- or dual-tropic HIV-1 virus at Screening or Baseline assessments.\n* Subjects with chronic renal insufficiency\n* Personal history of cardiac diseases.\n* History or presence of an abnormal ECG.\n* History of unstable ischemic heart disease or uncontrolled hypertension.\n* History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin.\n* Subjects who have received radiation therapy or cytotoxic chemotherapeutic agents and have not recovered from side effects.\n* Current treatment or treatment within 30 days or 5 half-lives with another investigational medication or current enrollment in another investigational drug protocol.\n* Subjects with unstable medical condition (s), which , in the opinion of the Investigator would compromise their participation in the trial"}, 'identificationModule': {'nctId': 'NCT00393120', 'briefTitle': 'Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study Exploring the Safety, Tolerability, PK & Virological Effect of Once Daily Oral Dosing of INCB009471 as Monotherapy for 14 Days in ARV-naïve/Limited ARV-experienced, HIV-1 Infected Pts.', 'orgStudyIdInfo': {'id': 'INCB 9471-201'}, 'secondaryIdInfos': [{'id': 'INCB 9471-201', 'type': 'OTHER', 'domain': 'Incyte Corporation'}, {'id': 'IND No.69,030'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A - INCB009471 100mg IR', 'description': 'INCB009471, 100 mg IR orally once daily', 'interventionNames': ['Drug: INCB009471']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B - INCB009471 300mg SR', 'description': 'INCB009471, 300 mg SR orally once daily', 'interventionNames': ['Drug: INCB009471']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment C - Placebo', 'description': 'Placebo matching INCB009471', 'interventionNames': ['Drug: Placebo comparator']}], 'interventions': [{'name': 'INCB009471', 'type': 'DRUG', 'description': '100mg SR (sustained release) orally once daily', 'armGroupLabels': ['Treatment A - INCB009471 100mg IR']}, {'name': 'INCB009471', 'type': 'DRUG', 'description': '300mg SR (sustained release) orally once daily', 'armGroupLabels': ['Treatment B - INCB009471 300mg SR']}, {'name': 'Placebo comparator', 'type': 'DRUG', 'description': 'Orally once daily', 'armGroupLabels': ['Treatment C - Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90069', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32960', 'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'zip': '02130', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '20037', 'city': 'Annandale', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.83039, 'lon': -77.19637}}], 'overallOfficials': [{'name': 'Richard Levy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Rich Levy, MD', 'oldOrganization': 'Incyte Corporation'}}}}